BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNICELL I.V.STATION

    MDR report key: 10394402 · Received August 11, 2020

    Report

    Report Number
    3011278888-2020-00016
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    June 9, 2020
    Report Date
    May 21, 2021
    Manufacturer
    OMNICELL, INC.
    Product Code
    NEP
    UDI-DI
    08056477790007
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF JANUARY 2020, THE ESTABLISHMENT REGISTRATION AND LISTING FOR THIS DEVICE WAS UPDATED TO OMNICELL, INC. FROM AESYNT, INC, WHICH WAS NOT REFLECTED IN THE ORIGINAL REPORT SUBMISSION. THEREFORE, THIS REPORT IS A CORRECTION TO THE MANUFACTURER LISTED IN SECTIONS D3 AND G1.

    Description of Event or Problem · 1

    ON (B)(6) 2020 AN I.V. STATION DEVICE PASSED AN UNDERDOSED SYRINGE PREPARATION. THE SYRINGE CONTAINED APPROXIMATELY 3 ML OF EPHEDRINE DRUG SOLUTION WHEN IT SHOULD HAVE CONTAINED 5 ML. THE DEVICE WAS MONITORED AND THE INCORRECT VOLUME ISSUE WAS NOT REPRODUCED. ROOT CAUSE HAS NOT BEEN ABLE TO BE DETERMINED AND NO REMEDIAL ACTION HAS BEEN TAKEN. INVESTIGATION IS ONGOING. THE PREPARATION WAS VISUALLY IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853533 OMNICELL I.V.STATION PHARMACY COMPOUNDING DEVICE NEP OMNICELL, INC. I.V. STATION 08056477790007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other